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Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

NCT01737762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2017-07-26

Study results available
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Summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Conditions

  • Venous Leg Ulcers

Interventions

BIOLOGICAL

HP802-247

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.

BIOLOGICAL

Vehicle

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Healthpoint

  • Tommy Lee, MSHS · Healthpoint

  • Robert Kirsner, MD · University of Miami

  • William Marston, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737762 on ClinicalTrials.gov